Differential Effects of Various Anesthetic Agents on Cognitive Function in Patients With Alzheimer's Disease

NCT01870453 | Withdrawn DMC

• 2 other identifiers: MassGH-001HAT-12-237963
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the effects of different anesthetic agents on cognitive function in patients with Alzheimer's disease (AD). The investigators will test the hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients with AD.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Dementia; Postoperative Care; Cognitive Reserve

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

  Cognitive function will be assessed using a battery of neuropsychological tests in the domains of attention and executive functions (Trail Making Test, Verbal Fluency Test, Category Switching Test, Symbol Digit Modalities Test), memory (Hopkins Verbal Learning Test-R, Brief Visual Memory Test-R), visuospatial functions (Benton Judgement of Line Orientation Test), and language (Category Fluency Test).

  1 week pre-operatively to 1 year post-operatively

Study Arms (4)

Isoflurane Anesthesia

Recruited subjects that were anesthetized with isoflurane for their surgery.

Sevoflurane Anesthesia

Recruited subjects that were anesthetized with sevoflurane for their surgery.

Desflurane Anesthesia

Recruited subjects that were anesthetized with desflurane for their surgery.

Propofol Anesthesia

Recruited subjects that were anesthetized with propofol for their surgery.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 study participants with mild-to-moderate AD who are scheduled to have elective noncardiac, nonneurologic, nonvascular surgery will be recruited at MGH. Surgeons will first introduce the study to patients at their preoperative surgical clinic visit. If a patient expresses interest in the study, and with permission of the surgeon, the patient will then be contacted by study staff at his/her PATA preoperative evaluation and medical optimization clinic visit. Recruitment, screening, and enrollment will then occur at the patient's PATA clinic visit.

You may qualify if:

• Patients diagnosed with Alzheimer's disease (AD) per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
• Patient recruitment permission granted by his/her surgeon
• Requires general anesthesia for elective noncardiac, nonneurologic, nonvascular surgery.

You may not qualify if:

• History of neurologic or psychiatric disease (i.e. stroke, psychosis, etc.)
• Non-native English speaker
• Severe visual or auditory disorder
• Sensitivity to sulfites (some propofol formulations at MGH may contain sodium metasulfite).
• Asthma (sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Alzheimer's Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

US (1)